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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CATHETER 20G X 1.16"IN WITH Y LUER CONNECTION SITE PERIPHERAL INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II CATHETER 20G X 1.16"IN WITH Y LUER CONNECTION SITE PERIPHERAL INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383406
Device Problems Detachment Of Device Component (1104); Crack (1135); Component Missing (2306)
Patient Problem No Information (3190)
Event Date 03/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device evaluation: nine customer samples were returned. Included were four (4) pegaus 24g catheters, two (2) intima ii 24g catheters, and three (3) intima ii 22g catheters. Eight (8) of the pieces had the catheter cracked from the inner aspect of the y-adapter and once piece was cracked from around the y-adapter. The samples were reviewed microscopically. It was observed that the catheter had obvious stretch. The manufacturer simulated the same conditions which found the same phenomenon as the complaint samples. The root cause for this issue are caused by major force based on a video the customer provided to the qa engineers. According to the customer complaint, the catheter can flex only 3-4 times before it cracks. Five samples from the same batch were used to perform the catheter toughness test according to the specification "put the catheter onto one plane and folder 2-sided 20 times at 180 degrees". No cracks or damage found. Five samples from the same batch were used to perform the catheter pull force test and found within specification. The device history record was reviewed and no abnormalities were found and product specifications were met. As this incident is not manufacturing related. The returned complaint samples were observed to have drag phenomenon and damage caused by extra force. Testing on the same batch of samples pass in-coming, in-process and out-going tests. An absolute root cause for this incident cannot be determined.
 
Event Description
It was reported that the suspect device was placed on the patient's left hand on (b)(6) 2016 for surgery. After surgery, the patient was moving restlessly, which caused the catheter to crack and detach. The nurse found part of the catheter missing. On (b)(6) 2016, the head nurse was informed and the patient had an x-ray of the left hand and lung but no broken catheter was detected.
 
Manufacturer Narrative
(b)(6). Sex - male. The patient was hospitalized for ureteral calculus, benign prostatic hyperplasia and vesical calculi. The suspect device was placed in the left forearm in the operating room. At 9 pm, the nurse found the catheter had fallen off and could not locate the catheter in the patient's room. Upon examination on (b)(6), there were no abnormalities noted upon palpation of the blood vessels of the arm. The x-ray was performed on the left arm and chest. The patient's condition was reported as stable and he was discharged from the hospital.
 
Event Description
The patient was hospitalized for ureteral calculus, benign prostatic hyperplasia and vesical calculi. The suspect device was placed in the left forearm in the operating room. At 9 pm, the nurse found the catheter had fallen off and could not locate the catheter in the patient's room. Upon examination on (b)(6), there were no abnormalities noted upon palpation of the blood vessels of the arm. The x-ray was performed on the left arm and chest. The patient's condition was reported as stable and he was discharged from the hospital.
 
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Brand NameBD INTIMA-II CATHETER 20G X 1.16"IN WITH Y LUER CONNECTION SITE
Type of DevicePERIPHERAL INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key5554212
MDR Text Key42061138
Report Number3006948883-2016-00015
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K100775
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number383406
Device Lot Number5166308
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/07/2016 Patient Sequence Number: 1
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